Patient baseline demographics and disease characteristics
| . | Ibrutinib intolerant (cohort 1; n = 44) . | Acalabrutinib intolerant∗ (cohort 2; n = 27) . | Total (N = 71) . |
|---|---|---|---|
| Male sex, n (%) | 23 (52.3) | 13 (48.1) | 36 (50.7) |
| Hispanic/Latino, n (%) | 2 (4.5) | 0 | 2 (2.8) |
| Age, median (range), y | 72 (49-91) | 68 (51-84) | 71 (49-91) |
| ECOG PS, n (%) | |||
| 0 | 26 (59.1) | 18 (66.7) | 44 (62.0) |
| 1 | 18 (40.9) | 7 (25.9) | 25 (35.2) |
| 2 | 0 | 2 (7.4) | 2 (2.8) |
| No. of prior anticancer regimens, median (range) | 1 (1-7) | 2 (1-6) | 1 (1-7) |
| Duration of prior ibrutinib therapy, median (range), mo | 12.9 (1.2-64.8) | 6.6 (3.1-46.4) | 9.8 (1.2-64.8) |
| Duration of prior acalabrutinib therapy, median (range), mo | NA | 5.7 (0.2-68.6) | 5.7 (0.2-68.6) |
| Cytopenia status, n (%) | |||
| Hemoglobin of ≤110 g/L | 6 (13.6) | 5 (18.5) | 11 (15.5) |
| Platelet count of ≤100 × 109/L | 5 (11.4) | 1 (3.7) | 6 (8.5) |
| Absolute neutrophil count of ≤1.5 × 109/L | 3 (6.8) | 0 | 3 (4.2) |
| Bulky disease, n (%) | |||
| LDi of <5 cm | 27 (61.4) | 22 (81.5) | 49 (69.0) |
| LDi of ≥5 cm | 8 (18.2) | 2 (7.4) | 10 (14.1) |
| No measurable disease | 9 (20.5) | 3 (11.1) | 12 (16.9) |
| Binet stage at CLL diagnosis, n (%) | |||
| A | 9 (20.5) | 3 (11.1) | 12 (16.9) |
| B | 4 (9.1) | 2 (7.4) | 6 (8.5) |
| C | 4 (9.1) | 0 | 4 (5.6) |
| Unknown | 21 (47.7) | 20 (74.1) | 41 (57.7) |
| Disease type, n (%) | |||
| CLL | 38 (86.4) | 25 (92.6) | 63 (88.7) |
| SLL | 6 (13.6) | 2 (7.4) | 8 (11.3) |
| Del(11q) mutation, n (%) | |||
| Present | 8 (18.2) | 2 (7.4) | 10 (14.1) |
| Absent | 30 (68.2) | 14 (51.9) | 44 (62.0) |
| Missing/unknown | 6 (13.6) | 11 (40.7) | 17 (23.9) |
| Del(17p) mutation, n (%) | |||
| Present | 4 (9.1) | 2 (7.4) | 6 (8.5) |
| Absent | 32 (72.7) | 14 (51.9) | 46 (64.8) |
| Missing/unknown | 8 (18.2) | 11 (40.7) | 19 (26.8) |
| Del(13q) monosomy mutation, n (%) | |||
| Present | 12 (27.3) | 5 (18.5) | 17 (23.9) |
| Absent | 23 (52.3) | 8 (29.6) | 31 (43.7) |
| Missing/unknown | 9 (20.5) | 14 (51.9) | 23 (32.4) |
| Unmutated IGHV, n (%) | |||
| Present | 10 (22.7) | 3 (11.1) | 13 (18.3) |
| Absent | 8 (18.2) | 4 (14.8) | 12 (16.9) |
| Missing/unknown | 26 (59.1) | 20 (74.1) | 46 (64.8) |
| TP53 mutation, n (%) | |||
| Present | 11 (25.0) | 5 (18.5) | 16 (22.5) |
| Absent | 27 (61.4) | 14 (51.9) | 41 (57.7) |
| Missing/unknown | 6 (13.6) | 8 (29.6) | 14 (19.7) |
| . | Ibrutinib intolerant (cohort 1; n = 44) . | Acalabrutinib intolerant∗ (cohort 2; n = 27) . | Total (N = 71) . |
|---|---|---|---|
| Male sex, n (%) | 23 (52.3) | 13 (48.1) | 36 (50.7) |
| Hispanic/Latino, n (%) | 2 (4.5) | 0 | 2 (2.8) |
| Age, median (range), y | 72 (49-91) | 68 (51-84) | 71 (49-91) |
| ECOG PS, n (%) | |||
| 0 | 26 (59.1) | 18 (66.7) | 44 (62.0) |
| 1 | 18 (40.9) | 7 (25.9) | 25 (35.2) |
| 2 | 0 | 2 (7.4) | 2 (2.8) |
| No. of prior anticancer regimens, median (range) | 1 (1-7) | 2 (1-6) | 1 (1-7) |
| Duration of prior ibrutinib therapy, median (range), mo | 12.9 (1.2-64.8) | 6.6 (3.1-46.4) | 9.8 (1.2-64.8) |
| Duration of prior acalabrutinib therapy, median (range), mo | NA | 5.7 (0.2-68.6) | 5.7 (0.2-68.6) |
| Cytopenia status, n (%) | |||
| Hemoglobin of ≤110 g/L | 6 (13.6) | 5 (18.5) | 11 (15.5) |
| Platelet count of ≤100 × 109/L | 5 (11.4) | 1 (3.7) | 6 (8.5) |
| Absolute neutrophil count of ≤1.5 × 109/L | 3 (6.8) | 0 | 3 (4.2) |
| Bulky disease, n (%) | |||
| LDi of <5 cm | 27 (61.4) | 22 (81.5) | 49 (69.0) |
| LDi of ≥5 cm | 8 (18.2) | 2 (7.4) | 10 (14.1) |
| No measurable disease | 9 (20.5) | 3 (11.1) | 12 (16.9) |
| Binet stage at CLL diagnosis, n (%) | |||
| A | 9 (20.5) | 3 (11.1) | 12 (16.9) |
| B | 4 (9.1) | 2 (7.4) | 6 (8.5) |
| C | 4 (9.1) | 0 | 4 (5.6) |
| Unknown | 21 (47.7) | 20 (74.1) | 41 (57.7) |
| Disease type, n (%) | |||
| CLL | 38 (86.4) | 25 (92.6) | 63 (88.7) |
| SLL | 6 (13.6) | 2 (7.4) | 8 (11.3) |
| Del(11q) mutation, n (%) | |||
| Present | 8 (18.2) | 2 (7.4) | 10 (14.1) |
| Absent | 30 (68.2) | 14 (51.9) | 44 (62.0) |
| Missing/unknown | 6 (13.6) | 11 (40.7) | 17 (23.9) |
| Del(17p) mutation, n (%) | |||
| Present | 4 (9.1) | 2 (7.4) | 6 (8.5) |
| Absent | 32 (72.7) | 14 (51.9) | 46 (64.8) |
| Missing/unknown | 8 (18.2) | 11 (40.7) | 19 (26.8) |
| Del(13q) monosomy mutation, n (%) | |||
| Present | 12 (27.3) | 5 (18.5) | 17 (23.9) |
| Absent | 23 (52.3) | 8 (29.6) | 31 (43.7) |
| Missing/unknown | 9 (20.5) | 14 (51.9) | 23 (32.4) |
| Unmutated IGHV, n (%) | |||
| Present | 10 (22.7) | 3 (11.1) | 13 (18.3) |
| Absent | 8 (18.2) | 4 (14.8) | 12 (16.9) |
| Missing/unknown | 26 (59.1) | 20 (74.1) | 46 (64.8) |
| TP53 mutation, n (%) | |||
| Present | 11 (25.0) | 5 (18.5) | 16 (22.5) |
| Absent | 27 (61.4) | 14 (51.9) | 41 (57.7) |
| Missing/unknown | 6 (13.6) | 8 (29.6) | 14 (19.7) |
del(11q), deletion in chromosome 11q; del(13q), deletion in chromosome 13q; del(17p), deletion in chromosome 17p; ECOG PS, Eastern Cooperative Oncology Group performance status; IGHV, immunoglobulin heavy chain variable region; LDi, longest diameter; NA, not applicable; TP53, tumor protein 53.
Includes patients intolerant of ibrutinib and acalabrutinib.